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Clinical Supply Agreement
"Need a Clinical Supply Agreement for a Phase II oncology trial where our Singapore-based pharmaceutical company will receive drug supplies from a manufacturer in Germany, with first delivery required by March 2025 and specific temperature control requirements."
1. Parties: Details of the supplier and recipient entities, including registration numbers and addresses
2. Background: Context of the agreement, including the clinical trial details and purpose of supply
3. Definitions: Key terms used throughout the agreement including Product, Specifications, GMP, Clinical Trial
4. Supply Obligations: Core obligations regarding the supply of clinical materials, including quantities, timelines
5. Quality Requirements: GMP compliance, specifications, testing requirements
6. Delivery and Storage: Delivery terms, storage conditions, handling requirements
7. Regulatory Compliance: Compliance with applicable laws, permits, licenses
8. Payment Terms: Pricing, payment schedule, invoicing requirements
9. Confidentiality: Protection of confidential information exchanged
10. Term and Termination: Duration of agreement and termination provisions
1. Manufacturing Change Control: Process for managing manufacturing changes when supplier is manufacturing the product
2. Technology Transfer: Terms for transfer of manufacturing technology when manufacturing process needs to be transferred
3. Safety Reporting: Procedures for adverse event reporting when supplier has direct involvement in safety monitoring
4. Insurance: Insurance requirements and coverage when specific insurance coverage is required
1. Product Specifications: Detailed technical specifications of the clinical supplies
2. Quality Agreement: Detailed quality requirements and responsibilities
3. Pricing Schedule: Detailed pricing information and structure
4. Supply Schedule: Delivery timeline and quantities
5. Technical Transfer Protocol: Details of technology transfer process if applicable
6. Safety Data Exchange Agreement: Procedures for safety data exchange between parties
7. Storage and Handling Requirements: Detailed storage and handling specifications
Authors
Applicable Laws
Background IP
Batch
Clinical Trial
Clinical Trial Protocol
Confidential Information
Delivery Date
Effective Date
Force Majeure Event
Good Manufacturing Practice (GMP)
Health Sciences Authority (HSA)
Intellectual Property Rights
Investigational Product
Manufacturing Process
Manufacturing Site
Order
Product
Product Specification
Quality Agreement
Quality Control
Quality Requirements
Regulatory Authority
Safety Data
Shelf Life
Specifications
Storage Requirements
Study
Supplier
Supply Schedule
Technical Transfer
Term
Territory
Trial Site
Working Day
Quality Standards
Manufacturing Requirements
Specifications
Regulatory Compliance
Delivery and Acceptance
Storage and Handling
Price and Payment
Ordering Process
Quality Control
Testing Requirements
Documentation
Record Keeping
Batch Release
Product Recalls
Change Control
Safety Reporting
Intellectual Property
Confidentiality
Data Protection
Warranties
Indemnification
Insurance
Force Majeure
Term and Termination
Dispute Resolution
Governing Law
Assignment
Subcontracting
Notices
Audit Rights
Export Control
Liability Limitations
Compliance with Laws
Amendment Process
Entire Agreement
Severability
Survival
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